CancerNCT04272346
Harnessing Generativity Among Young Adult Cancer Survivors
A study testing Writing for others, Processing + writing for others and Facts-only writing in people with Cancer and Young Adults, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Short, online interventions designed to enhance well-being may be particularly amenable for use with adolescent and young adult (AYA) cancer survivors (age 15-39 at diagnosis), an understudied group in the cancer community. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Cancer, Young Adults
- What is being tested?
- Writing for others, Processing + writing for others and Facts-only writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2020to 7 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosis of cancer (any type) between the ages of 15 and 39 years
- have completed primary treatment and are in remission (partial or complete)
- between the ages of 18 and 39 years
- fluent in English
- have access to the internet and email.
Who cannot join
- -none
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: The Effects of Prosocial Writing on Psychological Well-being: An Online Randomized Controlled Trial Among Young Adult Cancer Survivors
Short, online interventions designed to enhance well-being may be particularly amenable for use with adolescent and young adult (AYA) cancer survivors (age 15-39 at diagnosis), an understudied group in the cancer community. The benefits of psychological well-being on both physical and mental health outcomes are well-known and, in recent years, researchers and policymakers have begun to view the period of adolescence and young adulthood as a window of opportunity to instantiate lasting habits and behaviors. Growing evidence suggests that prosocial behavior-a behavior that can be reliably manipulated through a short online intervention-may have beneficial effects on well-being and physical health. This has yet to be tested in AYA cancer survivors.
Drawing from the literature on positive psychology and prosocial interventions, the proposed study will test the feasibility and efficacy of an 8-week online peer helping intervention designed to increase well-being among AYA cancer survivors. AYA cancer survivors (n = 176) will be recruited and randomized to one of three conditions: a peer helping condition, a cancer-specific writing plus peer helping condition, or a cancer-specific writing condition (control condition). The second group was added in response to a previous study, which found that writing about one's experience prior to helping other survivors may be more beneficial. Participants will complete a weekly writing activity once per week for 4 weeks, with instructions administered via a weekly email. Participants will also complete online assessments before, during, and after the 4-week intervention period.
- Conditions
- Cancer, Young Adults
- Being tested
- Writing for others, Processing + writing for others, Facts-only writing
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Writing for othersBehavioural
Participants will receive general instructions for completing the writing sessions and will be asked to write for at least 20 minutes per session. Topics covered in each session will vary and are related to common cancer-related themes (e.g., receiving a diagnosis, undergoing treatment, etc.). Participants will be instructed not to worry about grammar, spelling, or sentence structure and reminded that their responses will remain anonymous. Writing sessions (four in total) will be spaced 1 week apart, and participants will be instructed to write about their experience for the benefit of a newly-diagnosed cancer patient.
Processing + writing for othersBehavioural
Participants will receive general instructions for completing the writing sessions and will be asked to write for at least 20 minutes per session. Topics covered in each session will vary and are related to common cancer-related themes (e.g., receiving a diagnosis, undergoing treatment, etc.). Participants will be instructed not to worry about grammar, spelling, or sentence structure and reminded that their responses will remain anonymous. Writing sessions (four in total) will be spaced 1 week apart. For the first three writing sessions, participants will write their deepest thoughts and feelings regarding cancer diagnosis and treatment. In the final writing session, participants will be instructed to write about their experience for the benefit of a newly-diagnosed cancer patient.
Facts-only writingBehavioural
Participants will receive general instructions for completing the writing sessions and will be asked to write for at least 20 minutes per session. Topics covered in each session will vary and are related to common cancer-related themes (e.g., receiving a diagnosis, undergoing treatment, etc.). Participants will be instructed not to worry about grammar, spelling, or sentence structure and reminded that their responses will remain anonymous. Writing sessions (four in total) will be spaced 1 week apart. Unlike the previous conditions, participants will not be instructed to write about their experience for the benefit of a newly-diagnosed cancer patient.
| Study group | Role | What they receive |
|---|---|---|
| Peer helping condition | Experimental | Participants in the peer helping condition will be asked to write about their cancer experience with an emphasis on using the experience to benefit a newly-diagnosed AYA cancer patient. Receives: Behavioral: Writing for others |
| Processing + peer helping condition | Experimental | Participants in the processing + peer helping condition will be asked to first write about their deepest thoughts and feelings about their cancer experience (3 writings), then share advice to a newly-diagnosed AYA cancer patient (final writing). Receives: Behavioral: Processing + writing for others |
| Facts-only writing condition | Placebo comparator | Participants in the facts-only writing condition will be asked to write about their cancer experience. Unlike the previous conditions, they will not be instructed to write for the benefit of a newly-diagnosed AYA cancer patient. Receives: Behavioral: Facts-only writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in psychological well-being
Well-being within the past month will be measured at baseline, post-intervention, and the 1-month follow-up via the 14-item Mental Health Continuum-Short Form (MHC-SF). The MHC-SF is comprised of three empirically derived subscales: the 3-item Emotional Well-Being Subscale, the 6-item Psychological Well-Being Subscale, and the 5-item Social Well-Being Subscale. Higher scores on each subscale, and the total score overall (range: 0-56), indicate greater well-being.
Measured: At the baseline survey (the day the intervention begins), at the post-intervention survey (1 week after the final writing assignment), and at the 1-month follow-up
Secondary outcomes (12)
Change in depressive symptoms
Depressive symptoms over the past week will be measured at baseline, post-intervention, and the 1-month follow-up via the 20-item Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a measure of symptom severity, with higher scores (range: 0-60) indicating greater depressive symptoms.
Measured: At the baseline survey (the day the intervention begins), at the post-intervention survey (1 week after the final writing assignment), and at the 1-month follow-up
Change in anxiety
Symptoms of anxiety over the past 2 weeks will be measured at baseline, post-intervention, and the 1-month follow-up via the 7-item Generalized Anxiety Disorder- 7 (GAD-7). Higher scores on the GAD-7 (range: 0-21) indicate greater severity of symptoms.
Measured: At the baseline survey (the day the intervention begins), at the post-intervention survey (1 week after the final writing assignment), and at the 1-month follow-up
Change in perceived impact of cancer
Perceived impact of cancer will be measured at baseline, post-intervention, and the 1-month follow-up via the Impact of Cancer Scale, Version 2. The following subscales will be administered: positive self-evaluation (4 items; range: 4-20), worry (7 items; range: 7-35), body change concerns (3 items; range: 3-15), physical appearance concerns (3 items; range: 3-15), and altruism/empathy (4 items; range: 4-20. Higher scores on each subscale indicate greater perceived severity of impact.
Measured: At the baseline survey (the day the intervention begins), at the post-intervention survey (1 week after the final writing assignment), and at the 1-month follow-up
Change in health-related quality of life
Health-related quality of life over the past week will be measured at baseline, post-intervention, and the 1-month follow-up via 12-item Short Form Health Survey (SF-12). Higher scores on the SF-12 (range: 0-100) indicate greater quality of life.
Measured: At the baseline survey (the day the intervention begins), at the post-intervention survey (1 week after the final writing assignment), and at the 1-month follow-up
Change in pain intensity and interference
Pain intensity over the past week will be measured at baseline, post-intervention, and the 1-month follow-up using the 1-item PROMIS pain intensity questionnaire (range: 1-5). Pain interference over the past week will be measured at baseline, post-intervention, and the 1-month follow-up using the 4-item PROMIS pain interference questionnaire (range: 4-20). Higher scores indicate greater pain intensity and interference.
Measured: At the baseline survey (the day the intervention begins), at the post-intervention survey (1 week after the final writing assignment), and at the 1-month follow-up
Change in cognitive functioning
Cognitive functioning over the past week will be measured at baseline, post-intervention, and the 1-month follow-up using the 4-item PROMIS Cognitive Functioning Questionnaire (range: 4-20). Higher scores indicate greater cognitive functioning.
Measured: At the baseline survey (the day the intervention begins), at the post-intervention survey (1 week after the final writing assignment), and at the 1-month follow-up
Change in sleep quality and disturbance
Sleep quality and disturbance over the past week will be measured at baseline, post-intervention, and the 1-month follow-up using the 4-item PROMIS Sleep Disturbance Questionnaire (range: 4-20). Higher scores indicate greater sleep disturbance.
Measured: At the baseline survey (the day the intervention begins), at the post-intervention survey (1 week after the final writing assignment), and at the 1-month follow-up
Change in fatigue
Fatigue over the past week will be measured at baseline, post-intervention, and the 1-month follow-up using the 4-item PROMIS Fatigue Questionnaire (range: 4-20). Higher scores indicate greater fatigue.
Measured: At the baseline survey (the day the intervention begins), at the post-intervention survey (1 week after the final writing assignment), and at the 1-month follow-up
Change in social support
Social support will be measured at baseline, post-intervention, and the 1-month follow-up using the 21-item 2-way Social Support Scale. This scale measures 4 dimensions of social support: instrumental support received, instrumental support given, emotional support received, and emotional support given. A higher total score (range: 0-105) indicates more feelings of perceived support.
Measured: At the baseline survey (the day the intervention begins), at the post-intervention survey (1 week after the final writing assignment), and at the 1-month follow-up
Change in generativity
Feelings of generativity will be measured at baseline, post-intervention, and the 1-month follow-up using the 13-item Generativity Scale. This measure consists of two subscales: generative desire and generative achievement, with higher scores (range: 13-78) indicating greater desire/achievement.
Measured: At the baseline survey (the day the intervention begins), at the post-intervention survey (1 week after the final writing assignment), and at the 1-month follow-up
Change in positive and negative affect
Reports of positive and negative affect will be assessed at baseline, post-intervention, the 1-month follow-up, and at each writing session using the 10-item positive affect subscale and 10-item negative affect subscales of the Positive and Negative Affect Schedule (PANAS-X). Two additional adjectives were also included, happy and calm. Greater scores indicate higher feelings of positive (range: 10-50) and negative affect (range: 10-50).
Measured: At the baseline survey (the day the intervention begins), at each writing session, at the post-intervention survey (1 week after the final writing assignment), and at the 1-month follow-up
Change in fulfillment of psychological needs
Fulfillment of psychological needs will be measured at baseline, post-intervention, the 1-month follow-up, and at each writing session using the 9-item Balanced Measure of Psychological Needs. This item has three subscales: autonomy, connectedness, and relatedness, with higher scores (range: 9-45) indicating greater needs satisfaction.
Measured: At the baseline survey (the day the intervention begins), at each writing session, at the post-intervention survey (1 week after the final writing assignment), and at the 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start17 Aug 2020
- Primary completion7 Apr 2021
- Study completion7 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcie D. Haydon, MA, CPhil, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272346
- Sponsor's protocol ID
- IRB# 19-001945
- Status last verified
- Apr 2021
- First submitted
- 13 Feb 2020
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haydon MD, Stanton AL, Hoyt MA, Bower JE. A randomized controlled trial testing the benefits of prosocial writing in young adult survivors of adolescent and young adult cancer. Health Psychol. 2025 Sep;44(9):886-897. doi: 10.1037/hea0001512. Epub 2025 May 5.
PubMed 40323828
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Prosocial Writing on Psychological Well-being: An Online Randomized Controlled Trial Among Young Adult Cancer Survivors
- ClinicalTrials.gov ID
- NCT04272346
- Acronym / sponsor ID
- IRB# 19-001945
- Conditions
- Cancer, Young Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 7 Apr 2021 (actual)
- Study completion
- 7 Apr 2021 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Short, online interventions designed to enhance well-being may be particularly amenable for use with adolescent and young adult (AYA) cancer survivors (age 15-39 at diagnosis), an understudied group in the cancer community. The benefits of psychological well-being on both physical and mental health outcomes are well-known and, in recent years, researchers and policymakers have begun to view the period of adolescence and young adulthood as a window of opportunity to instantiate lasting habits and behaviors. Growing evidence suggests that prosocial behavior-a behavior that can be reliably manipulated through a short online intervention-may have beneficial effects on well-being and physical health. This has yet to be tested in AYA cancer survivors.
Drawing from the literature on positive psychology and prosocial interventions, the proposed study will test the feasibility and efficacy of an 8-week online peer helping intervention designed to increase well-being among AYA cancer survivors. AYA cancer survivors (n = 176) will be recruited and randomized to one of three conditions: a peer helping condition, a cancer-specific writing plus peer helping condition, or a cancer-specific writing condition (control condition). The second group was added in response to a previous study, which found that writing about one's experience prior to helping other survivors may be more beneficial. Participants will complete a weekly writing activity once per week for 4 weeks, with instructions administered via a weekly email. Participants will also complete online assessments before, during, and after the 4-week intervention period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Peer helping condition | Experimental | Behavioral: Writing for othersParticipants in the peer helping condition will be asked to write about their cancer experience with an emphasis on using the experience to benefit a newly-diagnosed AYA cancer patient. |
| Processing + peer helping condition | Experimental | Behavioral: Processing + writing for othersParticipants in the processing + peer helping condition will be asked to first write about their deepest thoughts and feelings about their cancer experience (3 writings), then share advice to a newly-diagnosed AYA cancer patient (final writing). |
| Facts-only writing condition | Placebo comparator | Behavioral: Facts-only writingParticipants in the facts-only writing condition will be asked to write about their cancer experience. Unlike the previous conditions, they will not be instructed to write for the benefit of a newly-diagnosed AYA cancer patient. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- diagnosis of cancer (any type) between the ages of 15 and 39 years
- have completed primary treatment and are in remission (partial or complete)
- between the ages of 18 and 39 years
- fluent in English
- have access to the internet and email.
Key exclusion criteria (1 listed)
- -none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Writing for othersParticipants will receive general instructions for completing the writing sessions and will be asked to write for at least 20 minutes per session. Topics covered in each session will vary and are related to common cancer-related themes (e.g., receiving a diagnosis, undergoing treatment, etc.). Participants will be instructed not to worry about grammar, spelling, or sentence structure and reminded that their responses will remain anonymous. Writing sessions (four in total) will be spaced 1 week apart, and participants will be instructed to write about their experience for the benefit of a newly-diagnosed cancer patient. | Behavioural | Peer helping condition |
| Processing + writing for othersParticipants will receive general instructions for completing the writing sessions and will be asked to write for at least 20 minutes per session. Topics covered in each session will vary and are related to common cancer-related themes (e.g., receiving a diagnosis, undergoing treatment, etc.). Participants will be instructed not to worry about grammar, spelling, or sentence structure and reminded that their responses will remain anonymous. Writing sessions (four in total) will be spaced 1 week apart. For the first three writing sessions, participants will write their deepest thoughts and feelings regarding cancer diagnosis and treatment. In the final writing session, participants will be instructed to write about their experience for the benefit of a newly-diagnosed cancer patient. | Behavioural | Processing + peer helping condition |
| Facts-only writingParticipants will receive general instructions for completing the writing sessions and will be asked to write for at least 20 minutes per session. Topics covered in each session will vary and are related to common cancer-related themes (e.g., receiving a diagnosis, undergoing treatment, etc.). Participants will be instructed not to worry about grammar, spelling, or sentence structure and reminded that their responses will remain anonymous. Writing sessions (four in total) will be spaced 1 week apart. Unlike the previous conditions, participants will not be instructed to write about their experience for the benefit of a newly-diagnosed cancer patient. | Behavioural | Facts-only writing condition |
Primary outcome
Change in psychological well-being
Time frame: At the baseline survey (the day the intervention begins), at the post-intervention survey (1 week after the final writing assignment), and at the 1-month follow-up
Well-being within the past month will be measured at baseline, post-intervention, and the 1-month follow-up via the 14-item Mental Health Continuum-Short Form (MHC-SF). The MHC-SF is comprised of three empirically derived subscales: the 3-item Emotional Well-Being Subscale, the 6-item Psychological Well-Being Subscale, and the 5-item Social Well-Being Subscale. Higher scores on each subscale, and the total score overall (range: 0-56), indicate greater well-being.
12 secondary outcomes
Change in depressive symptoms
Time frame: At the baseline survey (the day the intervention begins), at the post-intervention survey (1 week after the final writing assignment), and at the 1-month follow-up
Change in anxiety
Time frame: At the baseline survey (the day the intervention begins), at the post-intervention survey (1 week after the final writing assignment), and at the 1-month follow-up
Change in perceived impact of cancer
Time frame: At the baseline survey (the day the intervention begins), at the post-intervention survey (1 week after the final writing assignment), and at the 1-month follow-up
Change in health-related quality of life
Time frame: At the baseline survey (the day the intervention begins), at the post-intervention survey (1 week after the final writing assignment), and at the 1-month follow-up
Change in pain intensity and interference
Time frame: At the baseline survey (the day the intervention begins), at the post-intervention survey (1 week after the final writing assignment), and at the 1-month follow-up
Change in cognitive functioning
Time frame: At the baseline survey (the day the intervention begins), at the post-intervention survey (1 week after the final writing assignment), and at the 1-month follow-up
Change in sleep quality and disturbance
Time frame: At the baseline survey (the day the intervention begins), at the post-intervention survey (1 week after the final writing assignment), and at the 1-month follow-up
Change in fatigue
Time frame: At the baseline survey (the day the intervention begins), at the post-intervention survey (1 week after the final writing assignment), and at the 1-month follow-up
Change in social support
Time frame: At the baseline survey (the day the intervention begins), at the post-intervention survey (1 week after the final writing assignment), and at the 1-month follow-up
Change in generativity
Time frame: At the baseline survey (the day the intervention begins), at the post-intervention survey (1 week after the final writing assignment), and at the 1-month follow-up
Change in positive and negative affect
Time frame: At the baseline survey (the day the intervention begins), at each writing session, at the post-intervention survey (1 week after the final writing assignment), and at the 1-month follow-up
Change in fulfillment of psychological needs
Time frame: At the baseline survey (the day the intervention begins), at each writing session, at the post-intervention survey (1 week after the final writing assignment), and at the 1-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Derived from this study: PubMed 40323828Haydon MD, Stanton AL, Hoyt MA, Bower JE. A randomized controlled trial testing the benefits of prosocial writing in young adult survivors of adolescent and young adult cancer. Health Psychol. 2025 Sep;44(9):886-897. doi: 10.1037/hea0001512. Epub 2025 May 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Writing for others, Processing + writing for others and Facts-only writing in people with Cancer and Young Adults, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in psychological well-being (time frame: At the baseline survey (the day the intervention begins), at the post-intervention survey (1 week after the final writing assignment), and at the 1-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04272346, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.